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Niraparib tosylate - Generic Drug Details
What are the generic drug sources for niraparib tosylate and what is the scope of patent protection?
Niraparib tosylate
is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Niraparib tosylate has two hundred and forty-one patent family members in fifty countries.
One supplier is listed for this compound.
Summary for niraparib tosylate
| International Patents: | 241 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 34 |
| Clinical Trials: | 1 |
| Patent Applications: | 7 |
| DailyMed Link: | niraparib tosylate at DailyMed |
Recent Clinical Trials for niraparib tosylate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, Davis | Phase 2 |
| Janssen, LP | Phase 2 |
| National Cancer Institute (NCI) | Phase 2 |
Pharmacology for niraparib tosylate
| Drug Class | Poly(ADP-Ribose) Polymerase Inhibitor |
| Mechanism of Action | Poly(ADP-Ribose) Polymerase Inhibitors |
US Patents and Regulatory Information for niraparib tosylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | ZEJULA | niraparib tosylate | CAPSULE;ORAL | 208447-001 | Mar 27, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Glaxosmithkline | ZEJULA | niraparib tosylate | CAPSULE;ORAL | 208447-001 | Mar 27, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Glaxosmithkline | ZEJULA | niraparib tosylate | CAPSULE;ORAL | 208447-001 | Mar 27, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Glaxosmithkline | ZEJULA | niraparib tosylate | CAPSULE;ORAL | 208447-001 | Mar 27, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Glaxosmithkline | ZEJULA | niraparib tosylate | CAPSULE;ORAL | 208447-001 | Mar 27, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Glaxosmithkline | ZEJULA | niraparib tosylate | CAPSULE;ORAL | 208447-001 | Mar 27, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Glaxosmithkline | ZEJULA | niraparib tosylate | CAPSULE;ORAL | 208447-001 | Mar 27, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for niraparib tosylate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| United Kingdom | 0615907 | Start Trial |
| Brazil | PI0412909 | Start Trial |
| Ecuador | SP099484 | Start Trial |
| Japan | 5545690 | Start Trial |
| Poland | 1660095 | Start Trial |
| United Kingdom | 0603874 | Start Trial |
| Australia | 2004294790 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for niraparib tosylate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1633724 | PA2015016 | Lithuania | Start Trial | PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216 |
| 1633724 | S1500012 | Hungary | Start Trial | PRODUCT NAME: OLAPARIB |
| 1633724 | 92680 | Luxembourg | Start Trial | PRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218 |
| 2109608 | 1890020-9 | Sweden | Start Trial | PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE; REG. NO/DATE: EU/1/17/1235 20171120 |
| 1633724 | 122015000025 | Germany | Start Trial | PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216 |
| 2109608 | C20180013 00262 | Estonia | Start Trial | PRODUCT NAME: NIRAPARIIB;REG NO/DATE: EU/1/17/1235 20.11.2017 |
| 2109608 | 2018016 | Norway | Start Trial | PRODUCT NAME: NIRAPARIB ELLER ET; REG. NO/DATE: EU/1/17/1235 20171127 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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